Senior CSV Automation Lead

Johnson & Johnson Innovative Medicine; Leiden; On-site; EUR 54,000 - 85,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Well-being programs

Insurance plans

Job summary

Johnson & Johnson Innovative Medicine in Leiden, Netherlands, seeks a Computerized System Validation Execution Lead to drive validation activities for automation, digital, and GMP-relevant systems across capital projects and operations. You will coordinate validation across equipment, labs, facilities, and utilities, ensuring deliverables meet company standards and regulatory requirements.

As the Automation SME for CSV, you will mentor validation engineers, manage scope and resources, and

Qualifications

• Experience in GMP-regulated pharma/biotech/devices with CSV qualification.
• Strong knowledge of cGMP, GAMP 5, DI expectations, and ALCOA+.
• Ability to develop and review qualification documentation and manage change controls.

Responsibilities

• Lead CSV and qualification across the full system lifecycle from implementation to retirement.
• Define risk-based validation strategies and approve deliverables.
• Coach validation engineers and coordinate cross-functional stakeholders.

Skills

CSV Execution Lead

GAMP5

cGMP

Data Integrity

Regulatory readiness

Cross-functional leadership

Education

Bachelor's or Master's in Engineering/Automation/IT/Life Sciences

Tools

DeltaV

PLC

SCADA

MES

Job description

Johnson & Johnson Innovative Medicine in Leiden, Netherlands, seeks a Computerized System Validation Execution Lead to drive validation activities for automation, digital, and GMP-relevant systems across capital projects and operations. You will coordinate validation across equipment, labs, facilities, and utilities, ensuring deliverables meet company standards and regulatory requirements.

As the Automation SME for CSV, you will mentor validation engineers, manage scope and resources, and